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Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Job Description

Key Responsibilities

• Lead analytical method development activities for APIs, intermediates and raw materials using techniques such as HPLC, UPLC, GC, LC-MS/MS, GC-MS, and NMR.
• Plan, review, and approve analytical method validation, verification, and transfer studies in accordance with ICH, USP, EP, and other applicable regulatory requirements.
• Oversee analytical method transfer activities between R&D, QC and external laboratories to ensure successful implementation and lifecycle management.
• Ensure laboratory compliance with GMP, Data Integrity (ALCOA+), EHS requirements, SOPs, and internal quality systems while supporting regulatory inspections and customer audits.
• Manage operation, qualification, troubleshooting, and maintenance of analytical instruments, including HPLC, GC, LC-MS/MS, GC-MS, NMR and associated software.
• Provide scientific and technical leadership in investigating OOS, OOT, analytical deviations, and complex analytical challenges.
• Oversee the effective utilization and performance of advanced analytical platforms, particularly NMR, LC-MS/MS, and GC-MS, for structural characterization, impurity profiling, and process support.
• Act as the primary analytical representative during customer meetings, technical discussions, and global conference calls, providing scientific updates and project status.
• Prepare and review technical reports, protocols, specifications, analytical development reports, validation reports, and regulatory submission documents.
• Coordinate and respond to customer, regulatory, and audit-related queries with scientifically sound and timely justifications.
• Lead, mentor, and develop analytical scientists while driving continuous improvement initiatives, laboratory productivity, and technical excellence.
• Collaborate with Process R&D, Quality Assurance, Regulatory Affairs, Manufacturing, and external partners to support project milestones and commercial readiness.

Required Skills

• Strong expertise in analytical method development, validation, and transfer.
• In-depth knowledge of chromatographic and spectroscopic techniques, including Wet chemical analysis, HPLC, UPLC, HPLC-CAD, GC, LC-MS/MS, GC-MS, and NMR.
• Excellent understanding of GMP, Data Integrity, ICH guidelines, and regulatory expectations.
• Strong communication, presentation, and customer-facing skills.
• Proven leadership, team management, problem-solving, and project management capabilities.

Preferred Attributes

• Experience supporting customer audits, and technology transfer projects.
• Ability to manage multiple projects simultaneously in a fast-paced pharmaceutical R&D environment.
• Safety and Quality oriented.
• Demonstrated track record of delivering robust analytical solutions to support development and commercial manufacturing.

Qualification

• Master's Degree (M.Sc.) in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or a related discipline.
• 15-20 years of relevant experience in Pharmaceutical Analytical R&D, Contract Research Organizations (CROs).